Deployment handle for an introducer

ABSTRACT

A handle for an implant deployment device converts rotational movement into longitudinal movement in order to provide controlled release of one or more trigger wires. The handle also allows the trigger wire to be withdrawn into the device so that it does not need to be separately removed. A preferred handle includes a rotatable portion ( 120 ) and a slidable portion ( 122 ). Releasable locks ( 88, 188 ) ensure that the handle is used to carry out implant deployment steps in a specific order.

TECHNICAL FIELD

The present invention relates to a deployment handle for an introducer(also referred to hereinafter as an implant deployment device), and toan introducer including such a handle.

BACKGROUND OF THE INVENTION

The use of delivery devices or introducers employing catheters has longbeen known for a variety of medical procedures, including procedures forestablishing, re-establishing or maintaining passages, cavities orlumens in vessels, organs or ducts in human and veterinary patients,occlusion of such vessels, delivering medical treatments, and otherinterventions. For these procedures, it has also long been known todeliver an implantable medical device by means of a catheter, oftenintraluminally. For example, a stent, stent-graft, vena cava filter orocclusion device may be delivered intraluminally from the femoral arteryfor deployment.

For procedures in which a prosthesis or other medical device isimplanted into a patient, the device to be implanted is normally held ona carrier catheter or cannula of the introducer in a compressed stateand then released from the carrier catheter so as to expand to itsnormal operating state, prior to withdrawal of the catheter from thepatient to leave the implant in position.

A variety of delivery devices or introducers is known in the art. Thesegenerally involve positioning the implantable medical device on a distalpart of a delivery device, that is, at an end furthest from the externalmanipulation end used by the clinician during the deployment procedure.The implantable medical device is normally held at the distal end of acarrier catheter of the device by a suitable restraining mechanism,which may include restraining wires or trigger wires. It is alsoconventional for the introducer assembly to include an outer sheath tocover the implant in order to protect the medical device and also thepatient's vasculature or organs during the delivery process. Once themedical device has been positioned at the location in which it is to bereleased, the sheath is retracted along the carrier catheter to exposethe medical device. The medical device is then expanded, eitherautomatically, if the device is of the self-expanding type, or by asuitable expanding mechanism if not, such as by means of an expansionballoon.

Many endoluminal medical devices are radially self-expanding. Radiallyself-expanding devices are advantageous because they do not requirecomplicated and bulky balloon catheter systems for deployment. Suchdevices present a challenge, however, in that once one end of the deviceis released and anchored into the body lumen, subsequent positioning canbe difficult. This is particularly the case if the ends of the deviceinclude anchoring mechanisms to secure the prosthesis to the body lumen.As a consequence, many deployment devices have been proposed that allowthe self-expanding medical device to be partially expanded whileproviding a mechanism for retaining the proximal and distal extremitiesof the device until the main part of the device has been properlypositioned.

WO 2004/028399 discloses a stent graft deployment device for release ofa distal end of a stent graft before its proximal end. The deviceincludes a sliding handle to which the deployment catheter and aretention section or capsule are fixed mounted on a fixed handleassociated with a trigger wire release mechanism. The sliding handle canslide longitudinally with respect to the fixed handle.

WO 2005/032425 discloses an introducer including a retention section forretaining a proximal end of the prosthesis thereto. The proximal end ofthe prosthesis is retained by a trigger-wire. The trigger-wire can beremoved from the introducer to release the proximal end of theprosthesis into the body lumen.

WO 2005/037142 discloses another introducer for an expandableendovascular prosthesis. The introducer includes a retention section forretaining a proximal end of the prosthesis thereto, similar to that ofWO 2005/032425.

U.S. Pat. No. 6,866,669 discloses a device for retracting an outersheath in which there is provided, as one of two retraction mechanisms,a threaded shaft connected to the outer sheath, which can be controlledby rotation of a knurled knob.

U.S. Pat. No. 6,402,760 discloses a system which uses a motorised unitto retract a sheath.

U.S. Pat. No. 5,776,142 discloses an arrangement in which inner andouter catheters are attached to respective handle portions, which handleportions are connected to one another by means of a threaded element.Withdrawal of the sheath relative to the inner catheter is achieved bytwisting the handles relative to one another.

WO 98/20811 discloses a system in which retraction of a sheath isachieved by movement of a slider in a longitudinal direction of ahandle.

WO 00/67675 also discloses a longitudinally moveable actuator forwithdrawing an outer sheath, provided with a locking mechanism.

DE 44 20 142 discloses a handle attached to an applicator having twoguides for axial relocation of a transfer tube. One guide moves thetransfer tube back. The other guide is fixed to the handle and locks thetransfer tube when the first guide is moved forwards.

One problem with known deployment systems is that in order to deploy animplant correctly within a patient, different deployment steps need tobe taken in a very specific order. The surgeon or clinician must be verycareful to carry out the steps in the required order; mistakes couldresult in an abortive procedure and possible injury to a patient.Current handles include a number of components that must be removed bythe surgeon during the deployment procedure. These components then needto be discarded.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved deployment handle foran introducer or deployment device and an improved introducer ordeployment assembly.

According to a first aspect of the present invention there is provided ahandle for an implant deployment device including: a rotatable member;and a first trigger wire release mechanism, for withdrawing a triggerwire from a portion of an implant; wherein rotation of the rotatablemember causes the trigger wire release mechanism to withdraw a triggerwire so as to release a portion of an implant.

In an embodiment, the first trigger wire release mechanism is movablelongitudinally with respect to the handle, the first trigger wirerelease mechanism being engaged with the rotatable member such that uponrotation of the rotatable member the first trigger wire releasemechanism moves in a proximal direction with respect to the device.

Preferably, the first trigger wire to be released is attached to thefirst trigger wire release mechanism, such that movement of the firsttrigger wire release mechanism in a proximal direction results inwithdrawal of the first trigger wire.

In a preferred embodiment, the rotatable member is substantiallycylindrical and includes a lumen and an internal screw thread, whereinthe first trigger wire release mechanism is substantially cylindricaland is located within the internal lumen of the rotatable member andincludes an external screw thread engaged with the internal screw threadof the rotatable member, and wherein a guide member extends through thefirst trigger wire release mechanism to prevent rotation thereof whenthe rotatable member is rotated.

A stop may be provided so as to allow movement of the first trigger wirerelease mechanism for a limited distance in the proximal direction.

Preferably, a first releasable lock operable to prevent rotation of therotatable member is provided.

Preferably, the first releasable lock is operable to fix the rotatablemember to a non-rotatable portion of the handle in order to preventrotation of the rotatable member.

In a preferred embodiment, the handle includes a slidable portion.

The slidable portion is preferably located distally of the rotatablemember, and is able to be moved longitudinally towards the rotatablemember.

In an embodiment, the slidable portion is only able to movelongitudinally towards the rotatable member after movement of the firsttrigger wire release mechanism in a longitudinal direction.

A stop may be provided so as to allow movement of the first trigger-wirerelease mechanism for a limited distance in the proximal direction,wherein the slidable portion is only able to move longitudinally afterthe first trigger wire release mechanism has moved by said limiteddistance.

Preferably, movement of the slidable portion in a proximal directiondisengages the stop, thereby allowing the first trigger wire releasemechanism to move longitudinally in a proximal direction.

Preferably, a second trigger wire release mechanism is provided, whereinthe second trigger wire release mechanism is arranged to movelongitudinally in a proximal direction.

The second trigger wire release mechanism may be arranged to movelongitudinally in a proximal direction only after the stop has beendisengaged.

The first trigger wire release mechanism is preferably able to exert aforce in a proximal direction on the second trigger wire releasemechanism in order to cause the second trigger wire release mechanism tomove in a proximal direction.

In a preferred embodiment, the rotatable member is substantiallycylindrical and includes a lumen and an internal screw thread, the firsttrigger wire release mechanism is substantially cylindrical and islocated within the internal lumen of the rotatable member and includesan external screw thread engaged with the internal screw thread of therotatable member, a guide member extends through the first trigger wirerelease mechanism to prevent rotation thereof when the rotatable memberis rotated, and the second trigger wire release mechanism issubstantially cylindrical and is located within the internal lumen ofthe rotatable member proximal of the first trigger wire releasemechanism, and the second trigger wire release mechanism does notinclude an external screw thread engaged with the internal screw threadof the rotatable member.

The handle may include a second releasable lock operable to preventlongitudinal movement of the slidable portion.

Preferably, the second releasable lock is operable to fix the slidableportion to a non-slidable portion of the handle in order to preventlongitudinal movement of the slidable portion.

A stop may be provided so as to allow movement of the first trigger wirerelease mechanism for a limited distance in the proximal direction andthe second releasable lock may only be released after the first triggerwire release mechanism has moved by said limited distance.

In the preferred embodiment, the second releasable lock engages with theslidable portion of a handle and with a non-slidable portion of thehandle thereby preventing relative movement therebetween, wherein in thesecond releasable lock engages with the longitudinal member attached toand arranged to move with the first trigger wire release mechanism suchthat the second releasable member cannot be released whilst engaged withthe longitudinal member, whereby movement of the first trigger wirerelease mechanism in a proximal direction causes disengagement of thelongitudinal member from the second releasable lock.

In an embodiment, the trigger wire release mechanism is arranged torotate with a rotatable member.

Rotation of the trigger wire release mechanism may result in withdrawalof the trigger wire attached thereto.

Rotation of the trigger wire release mechanism may result in the triggerwire being wound around the trigger wire release mechanism to effectwithdrawal of the trigger wire.

The trigger wire release mechanism includes a circumferential groove inwhich a withdrawn trigger wire may be located.

A support member may be provided distally of the trigger wire releasemember, the support member operable to guide the trigger wire around thetrigger wire release mechanism.

According to a second aspect of the present invention, there is providedan implant deployment device including a handle as described above.

BRIEF DESCRIPTION OF THE DRAWING

Embodiments of the present invention are described below, by way ofexample only, with reference to the accompanying drawings, in which:

FIG. 1 illustrates a proximal component of a two-piece endovascularstent graft;

FIG. 2 illustrates a distal component of a two-piece endovascular stentgraft;

FIG. 3 illustrates a one-piece endovascular stent graft;

FIG. 4 shows a distal trigger-wire release mechanism;

FIG. 5 shows a proximal trigger-wire release mechanism;

FIG. 6 illustrates a deployment system for the proximal component ofFIG. 1;

FIG. 7 illustrates a deployment system for the distal component of FIG.2 or the one-piece stent graft of FIG. 3.

FIG. 8 is a perspective view of a first embodiment of a handle;

FIG. 9 shows a longitudinal cross-section of the handle of FIG. 8;

FIG. 10 shows a transverse cross-section through the line A-A of FIG. 9;

FIG. 11 is a perspective view of a component of the handle of FIG. 8;

FIG. 12 is a perspective view of a second embodiment of a handle;

FIG. 13 shows a longitudinal cross-section of the handle of FIG. 12;

FIG. 14 is a partially exploded view of the handle of FIG. 12;

FIG. 15 shows a transverse cross-section through the line B-B of FIG.13;

FIG. 16 is a top plan view of a modified version of the embodiment ofFIGS. 12 to 15;

FIG. 17 is a view in partial cross-section of the handle of FIG. 16;

FIG. 18 shows a longitudinal cross-section of the handle of FIG. 16;

FIG. 19 shows a longitudinal cross-section of a portion of the handle ofFIGS. 16 to 18;

FIG. 20 is a side view of a component illustrated in FIG. 19;

FIG. 21 is a top plan view of the component of FIG. 20;

FIG. 22 is a side view of a component of the handle of FIGS. 16 to 18;

FIG. 23 is a side view of a component of the handle of FIGS. 16 to 18;

FIG. 24 is a side view of a component of the handle of FIGS. 16 to 18;

FIG. 25 is a view of one end of the component of FIG. 24;

FIG. 26 is a view from the opposite side of the component of FIG. 24;

FIG. 27 is a view of the other end of the component of FIG. 24;

FIG. 28 is a view of an end of a component of the handle of FIGS. 16 to18;

FIG. 29 is a cross-sectional view of the component of FIG. 28;

FIG. 30 is a side view of a component of the handle of FIGS. 16 to 18;

FIG. 31 is a view of the proximal end of a component of the handle ofFIGS. 16 to 18;

FIG. 32 is a side view of the component of FIG. 29;

FIG. 33 is a view of the distal end of the component of FIG. 29;

FIG. 34 is a side view of a component of the handle of FIGS. 16 to 18;

FIG. 35 shows a longitudinal cross-section of a component of the handleof FIGS. 16 to 18;

FIG. 36 is a perspective view from the side (partially in cross-section)of a modified version of the handle of FIGS. 8 to 11;

FIG. 37 shows a longitudinal cross-section of the handle of FIG. 36; and

FIG. 38 is a side view of a portion of a third embodiment of a handle.

DETAILED DESCRIPTION

It is to be understood that the Figures are schematic and do not showthe various components to their actual scale. In many instances, theFigures show scaled up components to assist the reader in theunderstanding of the features disclosed therein.

In this description, when referring to an introducer or deploymentassembly, the term distal is used to refer to an end of a componentwhich in use is furthest from the surgeon during the medical procedure,including within a patient. The term proximal is used to refer to an endof a component closest to the surgeon and in practice in or adjacent anexternal manipulation part of the deployment or treatment apparatus.

On the other hand, when referring to an implantable medical device suchas a stent or stent graft, the term proximal refers to a location thatin use is closest to the patient's heart, in the case of a vascularimplant, and the term distal refers to a location furthest from thepatient's heart.

By way of introduction, and with reference to FIGS. 1 to 7, describedbelow is the applicant's Zenith TX2® TAA Endovascular Graft and Z-Trak™Plus Introduction System.

The Zenith TX2®TAA Endovascular Graft is a two- or one-piece cylindricalendovascular graft (the two-piece device has proximal and distalcomponents, which are shown in FIGS. 1 and 2 respectively). Theone-piece graft is shown in FIG. 3.

The stent grafts are constructed of full-thickness woven polyesterfabric 10 sewn to self-expanding stainless steel Cook-Z® stents 12 withbraided polyester and monofilament polypropylene suture 14.

For added fixation, the covered stent at the proximal end of theproximal component (FIG. 1) includes barbs 16, which protrude throughthe graft material 10. In addition, the bare stent 18 at the distal endof the distal component (FIG. 2) also includes barbs 16. The one-piecedevice (FIG. 3) includes both proximal and distal barbs 16.

To facilitate fluoroscopic visualisation of the stent graft, fourradiopaque markers 13 are positioned on each end of the proximal anddistal components and of the one-piece device.

The Zenith TX2® TAA Endovascular Graft is preloaded into the Z-Trak™Plus Introduction System. It has a sequential deployment method toprovide continuous control of the endovascular graft throughout thedeployment procedure. The Z-Track™ Plus Introduction System enablesprecise positioning before deployment of the proximal and/or distalcomponents and/or one-piece device.

The main body graft components are deployed from a 20 Fr or 22 FrZ-Trak™ Plus Introduction System. These systems use either a singletrigger-wire release mechanism (proximal component) or dual trigger-wirerelease mechanisms (distal component and one-piece device) to secure theendovascular graft onto the delivery system until released by thephysician. FIGS. 4 and 5 illustrate the distal trigger-wire attachment40 and the proximal trigger wire attachment 50 respectively.

To facilitate sheath withdrawal, each graft component is kept in alongitudinally stretched condition on the delivery system by lockingtrigger wires. These trigger-wires work in tandem to deliver sequentialcontrolled release of the Zenith TX2® TAA Endovascular Graft duringdeployment (see FIGS. 4 and 5).

FIG. 6 illustrates the external manipulation section of the Z-Trak™ PlusIntroduction System for delivery of a Zenith TX2® TAA Endovascular GraftProximal Component. As indicated above, the proximal component is loadedat the distal end (not shown) of the introducer system. The introducersystem includes a trigger-wire release knob 1 having a safety screw 62.The trigger-wire release knob 1 is attached to the trigger-wireattachments 40, 50 (see FIGS. 4 and 5) that restrains the distal andproximal ends of the proximal component to the introducer. As indicatedabove, the proximal component is restrained on the device by a singletrigger-wire release mechanism.

In order to deploy the proximal component in a patient, the introduceris firstly inserted through the patient's vasculature until its distalend reaches the site of the deployment. A sheath (not shown) iswithdrawn to uncover the proximal component and allow it to expand.Whilst the central portion of the proximal component is able to expand,the proximal and distal ends remain in a constrained configuration bymeans of the trigger-wire attachments 40, 50.

The surgeon or clinician then loosens the safety screw 62 which enablesremoval of the trigger-wire release knob 1 and withdrawal and subsequentremoval of the trigger-wire. As the trigger-wire is withdrawn, theproximal end of the proximal component is released from the deploymentdevice. Further withdrawal of the trigger-wire subsequently releases thedistal attachment 40 from the introducer. It is important that all ofthe trigger wires are removed prior to withdrawal of the deliverydevice.

For deployment of the distal component of the two-piece graft and fordeployment of the one-piece graft, it is advantageous to deploy thedistal end of the component prior to its proximal end. This is in orderto avoid the “windsock” effect caused by blood flow from the proximal tothe distal direction. For this reason, the distal component and theone-piece graft are restrained by a dual trigger-wire release mechanism(as indicated above).

FIG. 7 illustrates the Z-Trak™ Plus Introduction System for delivery ofthe distal component or of a one-piece graft. To deploy the distalcomponent or a one-piece graft as illustrated in FIGS. 2 and 3 above,the deployment device illustrated in FIG. 7 is introduced into a patientto the site of deployment. The sheath (not shown) is partially withdrawnto allow the central section of the graft to expand. Although the middlesection of the graft expands, the proximal and distal ends arerestrained on the deployment device. Furthermore, the distal end of thedistal component or one-piece graft remains within the sheath or aretaining collar where provided.

As indicated above, the distal end of the distal component or theone-piece graft is released first. In order to do this, the surgeon orclinician releases the safety screw 62, which allows removal of thetrigger-wire release mechanism 1 and its associated trigger-wire. Thedistal end of the distal component or one-piece graft is thus releasedfrom the introducer but is still retained within the distal end of thesheath or retaining collar. The next step is to release a safety screw72 located on a telescoping handle 2 to which the sheath or retainingcollar is attached. This allows the telescoping handle to be withdrawnin a proximal direction thereby further withdrawing the sheath orretaining collar from the distal end of the distal component orone-piece graft. The distal end of the distal component or one-piecegraft is then thus fully released.

In order to deploy the proximal end of the distal component or one-piecegraft, the next step is to release the proximal trigger-wire attachment50, which is attached to a proximal trigger-wire release mechanism 3. Aproximal trigger wire safety screw 74 is released, then the proximaltrigger-wire release mechanism 3 is removed from the device along withits associated trigger-wire. This allows the proximal end of the distalcomponent or one-piece graft to expand fully.

The introducer can then be removed from the patient. Once again, it isimportant to make sure that all trigger-wires are removed prior towithdrawal of the delivery system. As the trigger wires may beapproximately 1 metre in length, this can be quite awkward. It can beseen from the above that the order of the steps taken to remove thevarious trigger wire release mechanisms is very important to ensurecorrect positioning and deployment of the stent graft.

A first embodiment of an improved handle for trigger wire release is nowdescribed with reference to FIGS. 8 to 11. The handle of the firstembodiment is particularly intended for deploying the proximal componentof a two-piece graft system such as that described above, but other usesmay be envisaged.

The handle includes a stationary section 80 and a rotatable section 82.The stationary section 80 includes a threaded connector 84 for attachingthe handle to an implant deployment device. The stationary section 80has proximal and distal portions connected by a longitudinal portion 86,which extends along the longitudinal axis of the rotatable section 82,internally of the rotatable section 82.

The rotatable section 82 has a generally cylindrical shape which has aslight oval or rounded outer contour. It is arranged between theproximal and distal portions of the stationary section 80 of the handle.The longitudinal portion 86 of the stationary section 80 of the handleextends through a lumen of the rotatable section 82. The internal wallof the rotatable section 82 is provided with a screw thread 90, thepurpose of which is described below.

As can be best seen in FIG. 10, the longitudinal portion 86 of thestationary section 80 of the handle is provided with an aperture 100.Aligned with the aperture 100, there is provided an aperture 98 in thewall of the rotatable section 82 of the handle. The aperture 98accommodates a thumb screw, or pin, 88. The thumb screw 88 has a headportion that can be manipulated by the physician in order to rotate thethumb screw 88. The thumb screw 88 also includes a tail portion 102 thatextends through the aperture 98 and extends towards the longitudinalportion 86 of the stationary section 80 of the handle. The end of thetail portion 102 of the thumb screw 88 extends through the aperture 100in the longitudinal portion 86 of the stationary section 80 of thehandle.

A bushing 93 is provided within the lumen of the substantiallycylindrical rotatable section 82 of the handle. The bushing 93 can beseen in greater detail in FIG. 11. As shown in FIG. 9, the bushing 33 isarranged radially around the longitudinal portion 86 of the stationarysection 80 of the handle.

The bushing 93 includes a notch 110 in its inner wall. The notch 110engages with a guide rod 94 running longitudinally through the handle.The outer wall of the bushing 93 includes a recess 112 to which atrigger wire that retains the proximal and distal ends of a proximalcomponent of a two-piece stent graft (see FIGS. 4 and 5) is attached ina suitable manner. An outer tubing (not shown) may be provided to holdthe trigger wire in place. Although not shown, the bushing 93 isprovided with a threading on its outer wall to engage with the threading90 provided in the handle.

The above-described handle is particularly envisaged for use indeployment of the proximal component of a two-piece stent graft asillustrated in FIG. 1. The proximal component is introduced to thedesired site of deployment within a patient in the usual manner. Thesheath retaining the proximal component in its compressed configurationis withdrawn, which allows the central section of the proximal componentto expand as described above. A single trigger wire is used to retainboth the proximal and distal ends of the proximal component to thedeployment device as illustrated in FIGS. 4 and 5. The above-describedhandle is then used to release the trigger wire as follows.

Firstly, it is to be noted that the rotatable part 82 of the handle asshown in FIGS. 8 to 10 cannot be rotated. This is because the thumbscrew 88 is engaged with the apertures 98, 100. This therefore locks thestationary part of the handle to the rotatable part of the handle. Thus,any attempt to rotate the rotatable section 82 of the handle is blocked.Therefore, the first step to be taken by the surgeon is to release thethumb screw 88. Once this has been released, rotation is possible.

As the rotatable part 82 of the handle is rotated with respect to thestationary part 80 of the handle, the bushing 93 to which the triggerwire is attached moves in a proximal direction due to its engagementwith the threading 90. The bushing 93 is itself prevented from rotatingby engagement with the rod 94 along which it slides. As the bushing 93moves in a proximal direction, the release wires attached thereto arepulled also in a proximal direction thereby releasing the stent graft.

Continued rotation of the rotatable part 82 of the handle causes thebushing 93 to move to the proximal-most end of the handle. As it doesso, the trigger wire is pulled into the deployment catheter; furtherdiscarding of the trigger wire is thus unnecessary.

The above-described handle provides many advantages over currentdesigns. Deployment is very controlled since rotation of the rotatablesection 82 of the handle is converted into a very small amount oftranslational movement of the bushing 93 in the proximal direction.Therefore, there is no sudden movement when friction is overcome: themovement is substantially continuous. This results in more precisecontrol, and also in the surgeon needing to apply less force to effectwithdrawal of the trigger wire or wires. As indicated above, a furtheradvantage is that withdrawal of the trigger wire into the catheter meansthat this can be removed from the patient at the same time as removal ofthe implant deployment device itself.

Many modifications to the above-described embodiment may be made. Forexample, the handle could be modified to withdraw also a sheath coveringthe medical device. The skilled person will readily be able to determinean appropriate coupling of the handle mechanism to the sheath assemblyform the teachings herein and common general knowledge.

A second embodiment of a handle is described with reference to FIGS. 12to 15. The second embodiment is particularly envisaged for deploying thedistal component of a two-piece graft system such as that describedabove (see FIG. 2), or for deploying a one-piece graft as describedabove (see FIG. 3). It is particularly useful where one end (forexample, the distal end) of a graft should be deployed prior to theproximal end.

The second embodiment is in many respects similar to the firstembodiment described above with reference to FIGS. 8 to 11. However,this embodiment of the handle includes two separate handle portions 120,122. The two handle portions 120, 122 are axially aligned such that oneof the handle portions 120 (hereinafter referred to as the rotatableportion 120) is arranged proximally of the other handle portion 122(hereinafter referred to as the slidable portion 122). The rotatableportion 120, in particular, is similar to the handle of the firstembodiment described above, in that it includes a stationary section 80and a rotatable section 82. There is provided, however, an overlapbetween the walls of the stationary section 80 and the rotatable section82.

The rotatable portion 120 also includes a bushing 93 (hereinafterreferred to as the second bushing 93) arranged radially around thelongitudinal portion 86 of the stationary section 80. The trigger wiresrestraining the ends of the stent graft (see FIGS. 4 and 5) are attachedto the second bushing 93. However, the second bushing 93 of the secondembodiment does not include an external thread. Instead it is able toslide within the rotatable portion 120 of the handle. It is sized tohave an interference fit within the rotatable portion 120 of the handle,thus requiring some force from another component in order to be able tomove.

The rotatable portion 120 of the second embodiment also includes a firstbushing 193. This does include an external thread 130, as can best beseen in FIG. 13. This mates with the threading 90 provided on theinternal wall of rotatable section 82 of the rotatable portion 120 ofthe handle. The first bushing 193 includes a longitudinal grooveextending through its wall, the purpose of which will be describedbelow.

As with the first embodiment of the handle, the rotatable portion 120 ofthe handle includes a thumbscrew 88, or alternatively a pin, hereinafterreferred to as a first safety screw 88. The first safety screw 88extends through an aperture 98 within the wall of the rotatable section82 of the rotatable portion 120 of the handle, and also through analigned aperture 198 provided in the wall of the stationary section 80of the rotatable portion 120 of the handle. The aligned apertures areprovided within the region of overlap between the stationary section 80and the rotatable section 82.

Extending from the distal end of the rotatable portion 120 of the handleis a middle portion 124 that connects the rotatable portion 120 with theslidable portion 122. The middle portion 124 is generally cylindrical inshape, but includes opposed flat surfaces on its external wall, thepurpose of which will be described below. The middle portion 124 alsoincludes an indentation 134, which in this embodiment is circular. Thiscan best be seen in FIG. 14. The purpose of the indentation 134 isdescribed below. The middle portion 124 is coaxial with the longitudinalportion 86 of the stationary section 80 of the rotatable portion 120 ofthe handle. The middle portion 124 extends partially into a lumen of theslidable portion 122 of the handle, to provide a small overlap betweenthese portions.

The slidable portion 122 of the handle includes a threaded connector 84at its distal end for attaching the handle to an implant deploymentdevice or introducer. It also includes an aperture 132 within in itswall in the region of overlap between the slidable portion 122 and themiddle portion 124. The aperture 132 can be aligned with the indentation134 provided in the middle portion 124 of the handle. A thumbscrew 188,alternatively a pin, hereinafter referred to as the second safety screw188, is shown in FIG. 13 as engaged through the aperture 132 and intothe indention 134. The second safety screw 188 includes a threadingwhich engages with threading provided in the aperture 132. This can bestbe seen in FIG. 15. The second safety screw 188 further includes aaperture 150 for receiving a first safety rod 194.

The first safety rod 194 can best be seen in FIG. 13. It includes ashoulder 136 at its proximal end, which engages with the proximal faceof the first bushing 193. The first safety rod 194 extends through thelongitudinal groove provided in the first bushing 193 and extendsdistally from the rotatable portion 120 of the handle towards theslidable portion 122 of the handle. The distal end of the first safetyrod 194 extends through the aperture 150 of the second safety screw 188(see FIG. 15).

A second safety rod 294 is also provided in this second embodiment ofthe handle. The second safety rod 294 extends along one of the flatsurfaces of the middle portion 124 of the handle and continues along thelongitudinal portion 86 of the stationary section 80 of the rotatableportion 120 of the handle. The second safety rod 294 includes shoulders131, 133 at proximal and distal ends respectively. The distal shoulder133 engages with an indentation in the internal wall of the slidableportion 122 of the handle. The second safety rod 294 extends through thelumen of the first bushing 193, and its purpose is described in greaterdetail below.

It can be seen by the described arrangement of the components of thehandle of the second embodiment, and as illustrated in the Figures, thatthe safety screws 88, 188 respectively prevent rotation of the rotatablesection 82 of the rotatable portion 120 of the handle, and also preventaxial movement of the slidable portion 122 of the handle with respect tothe rotatable portion 120 of the handle. In particular, it can be seen,firstly, that the first safety screw 88 prevents rotation of therotatable section 82 of the rotatable portion 120 of the handle withrespect to the stationary section 80 due to its engagement with theapertures 98, 198 provided in the respective sections of the rotatableportion 120 of the handle in the region of overlap. Engagement of thesecond safety screw 188 with the aperture 132 and the indentation 134prevents sliding of the slidable portion 122 of the handle along themiddle portion 124.

As indicated above, the second safety screw 188 is provided with athreading, and thus the second safety screw 188 must be rotated in orderto be removed. However, in the situation illustrated in the Figures,rotation of the second safety screw 188 is prevented due to engagementof the first safety rod 194 in the aperture 150 of the second safetyscrew 188.

The first safety rod 194 must be removed from the aperture 150 beforethe second safety screw 188 can be removed: The first safety rod 194 isremoved from the aperture 150 by rotating the rotatable section 82 ofthe rotatable portion 120 of the handle to cause movement in a proximaldirection of the first bushing 193, and thus also of the first safetyrod 194, which is engaged therewith by means of the shoulder 136. Inorder to allow this rotation, the surgeon must remove the first safetyscrew 88 from the apertures 98, 198 with which it is engaged.

In use, a distal component of a two-piece stent graft as illustrated inFIG. 2, or a one-piece stent graft as illustrated in FIG. 3 isintroduced to the desired site of deployment within a patient in theusual manner. The sheath retaining the stent graft in its compressedconfiguration is withdrawn, which allows the central section of thestent graft to expand as described above. The stent graft is restrainedby a dual trigger-wire release mechanism, and this embodiment of thehandle could be used to deploy the proximal end of the stent graftbefore the distal end of the stent graft. The proximal trigger wire isattached to the second bushing 93, whereas the distal trigger wire isattached to the first bushing 193 within the rotatable portion 120 ofthe handle.

The first stage is for the surgeon to release the first safety screw 88.Once the first safety screw 88 has been removed, rotation of therotatable section 82 of the rotatable portion 120 of the handle ispossible. Rotation causes proximal movement of the first bushing 193 dueto its engagement with the threading 90. Rotation of the first bushing193 itself is prevented by its engagement with the second safety rod294, along which it slides. Proximal movement of the first bushing 193causes proximal movement also of the first safety rod 194 due toengagement of the shoulder 136 with the first bushing 193. The distaltrigger wire is thus withdrawn, thereby releasing the distal end of theimplant. The trigger wire constraining the bare stent 18 at the distalend of the implant is released, but the bare stent 18 is still retainedwithin a cap covering the distal end of the stent graft.

The first bushing 193 can move in a proximal direction along the secondsafety rod 294 until it reaches the proximal shoulder 131 of the secondsafety rod 294, at which point further rotation of the rotatable section82 of the rotatable portion 120 of the handle is prevented. This informsthe surgeon that this stage of deployment (release of the distal end ofthe implant) has been completed.

Once the first safety rod 194 has been withdrawn from the aperture 150of the second safety screw 188, it is possible for the surgeon to rotatethe second safety screw 188, thereby removing it from engagement withthe aperture 132 and the indentation 134. At this point, it is thenpossible to slide the slidable portion 122 of the handle over the middleportion 124 of the handle. The slidable portion 122 of the handle isattached to the cap covering the bare stent 18 at the distal end of thestent graft. Sliding the slidable portion 122 of the handle in aproximal direction thus results in uncovering of the bare stent 18 bycausing proximal movement of the cover, enabling the bare stent 18 toexpand and engage with the vessel wall.

On sliding the slidable portion 122 of the handle in a proximaldirection the proximal shoulder 131 of the second safety rod 294 movesin a proximal direction relative to the first bushing 193. Since thefirst bushing 193 is no longer engaged with the proximal shoulder 131 ofthe second safety rod 294, further rotation of the rotatable section 82of the rotatable portion 120 of the handle with respect to thestationary section 80 of portion 120 of the handle is enabled.

Upon further rotation of the rotatable portion 120 of the handle, thefirst bushing 193 once again moves in a proximal direction, eventuallymeeting the second bushing 93. As indicated above, the second bushing 93is able to slide in a proximal direction when sufficient force (around2.5 kg) is applied. Continued rotation of the rotatable section 80 ofthe handle causes the first bushing 193 to exert a force against thesecond bushing 93 in a proximal direction resulting in proximal movementof both bushings 93,193. This movement can continue until the proximalface of the first bushing 193 once again abuts the shoulder 131 of thesecond safety rod 294.

The proximal movement of the second bushing 93 to which the proximaltrigger wires are attached causes withdrawal of the proximal triggerwire attachment 50, and subsequent release of the proximal end of theimplant. The proximal trigger wires are withdrawn into the deploymentcatheter; it is therefore unnecessary to discard of these separately.

The above-described embodiment provides several advantages. The handleitself prevents the surgeon from carrying out the deployment steps in anincorrect order.

Rotational movement of the handle is translated into axial movement ofthe bushings 93, 193. The rotational movement can prevent the generationof axial forces when initial withdrawal friction is overcome; themovement in the axial direction is therefore substantially smooth andcontinuous. This provides greater control of trigger wire withdrawal.

The trigger wires are withdrawn into the deployment catheter, whichmeans they do not need to be separately removed: they can simply beremoved from the patient at the same time as the deployment device.

The skilled person will appreciate that many modifications can be madeto the above-described embodiment.

FIGS. 16 to 18 illustrate a modified version of the embodiment of thehandle illustrated in FIGS. 12 to 15. It can be seen from FIGS. 16 to 18that the handle is similar in many respects. However, this modifiedversion includes many additional features, which may be combined and/orinterchanged with features of the handle illustrated in FIGS. 12 to 15(and in certain respects with the embodiment of the handle illustratedin FIGS. 8 to 11) as appropriate.

As above, the handle includes a rotatable portion 120 and a slidableportion 122. A middle portion 124 is provided between the rotatableportion 120 and the slidable portion 122. The function of the modifiedversion of the handle illustrated in FIGS. 16 to 18 is largely the sameas that of the handle illustrated in FIGS. 12 to 15, and will bedescribed in detail below. There now follows, however, a detaileddescription of some of the specific features of the version of thehandle illustrated in FIGS. 16 to 18.

FIG. 19 illustrates the first safety screw 88 and the second safetyscrew 188. The safety screws 88, 188 each include a post 192, each ofwhich engages with a respective locking pin rotation member 190. Thelocking pin rotation member can be seen in more detail in FIGS. 20 and21. The post 192 has a square cross-section, which fits within a squarecross-section recess 210 within the locking pin rotation member 190. Thelocking pin rotation members 190 extend through the apertures 98, 198provided between the stationary section 80 and the rotatable section 82of the rotatable portion 120 of the handle for the first safety screw88, and through the aperture 132 within the region of overlap betweenthe slidable portion 122 and the middle portion 124 for the secondsafety screw 188. The locking pin rotation member 190 for the secondsafety screw 188 extends into the indentation 134 provided in the middleportion 124 of the handle, and also engages with the first safety rod194, as can best be seen in FIG. 19. The locking pin rotation members190 include an external screw thread that engages with an internal screwthread within the apertures 98, 132.

The thumb screws illustrated in FIG. 19 may be twisted 180 degrees inorder to be released (in this embodiment the second safety screw 188cannot be twisted until the first safety rod 194 has been withdrawn outof engagement with the locking pin rotation member 190). Twisting of thethumb screw 88, 188 causes corresponding rotation of the locking pinrotation member 190, which by engagement of the screw threads is causedto be moved outwardly from recess 210 of the locking pin rotation member190. This unlocks the rotatable section 82 from the stationary section80 of the rotatable portion of the handle with respect to the firstsafety screw 88. Release of the second safety screw 188 has the effectof unlocking the slidable portion of the handle 122 from the middleportion of the handle 124. An advantage of this modification is thatrotating the thumbscrew by 180 degrees is sufficient for release. Thethumbscrew does not need to be completely removed, and so a surgeon doesnot need to find somewhere to dispose of a removed thumbscrew.

The first safety rod 194 and the second safety rod 294 are illustratedin more detail in FIGS. 22 and 23. The first safety rod 194 includes aproximal shoulder 136 and a radially outwardly protruding portion 220(or bump) that acts as a positioning locator. The shoulder 136 engageswith the proximal face of the first bushing 193.

The second safety rod 294 includes a shoulder 131 at its proximal end,which engages with a green-coloured marker ring 26. The second safetyrod 294 also includes a radially outwardly extending protrusion 230 (orbump) approximately half way along its length, and a radially inwardlyextending protrusion 232 between the shoulder 131 and the radiallyoutwardly extending protrusion 230. The radially outwardly extendingprotrusion 230 is able to provide a “stop” function in conjunction witha rotation lock 9 (described in more detail below). The radiallyinwardly extending protrusion 232 acts as a positioning locator.

A locking ring 9 is provided within the rotatable portion 120 of thehandle. The locking ring 9 is in the form of a bushing surrounding thelongitudinal portion 86 of the stationary section 80 of the rotatableportion 120 of the handle. It is located at the most distal end of therotatable section 120 of the handle, distally of the first bushing 193.The rotation lock 9 includes outwardly extending flaps 242. The flaps242 extend radially outwardly at a shallow angle in the same direction.They are, however, resilient. It can therefore be seen that by providingcorresponding abutments extending radially inwardly from the inner wallof the rotatable section 82 of the handle, rotation in one directiononly of the rotatable section 82 of the handle around the rotation lock9 is allowed, whilst rotation in other direction is prevented. Rotationof the rotation lock 9 itself within the rotatable portion 120 of thehandle is prevented by provision of a flat surface on the longitudinalportion 86 of the stationary section 80 of the rotatable portion 120 ofthe handle and a corresponding flat surface on the inner wall of thelocking ring 9.

The locking ring 9 also includes a groove 252 through which the secondsafety rod 294 extends. Within the groove 252 there is provided achamfered projection 270, which can provided a stop for the secondsafety rod 294 in conjunction with the radially outwardly extendingprotrusion 230 of the second safety rod 294.

As indicated above, the shoulder 131 of the second safety rod 294engages with a marker ring 26. The marker ring 26 is illustrated in moredetail in FIGS. 28 and 29. In the preferred embodiment, the marker ringis coloured green, for reasons which will be explained below.

The marker ring 26 is located within the rotatable portion 120 of thehandle distally of the second bushing 93, but proximally of the firstbushing 193. Similarly to the second bushing 93, the marker ring 26 doesnot contain any external threading, and therefore does not move when therotatable section 82 of the rotatable portion 120 of the handle isrotated. As can be seen in FIG. 28, the inner wall of the marker ring 26includes a radially inwardly projecting element 280. This engages with agroove running along the longitudinal section 26 of the stationarysection 80 of the rotatable portion 120 of the handle, and also a flatsurface 282 that engages against a flat surface 282 of the longitudinalsection 86 of the stationary section 80 of the rotatable portion 120 ofthe handle. The projection 280 and the flat surface 282 together preventthe marker ring 26 from rotating when the rotatable portion 82 of thehandle is rotated. The marker ring includes a recess 290 (best seen inFIG. 29). The shoulder 131 of the second safety rod 294 engages with therecess 290.

FIG. 30 illustrates the middle portion 124 of the handle in more detail.The middle portion 124 can be considered a sliding rod extending fromthe distal end of the rotatable portion 120 of the handle. As can bestbe seen in FIG. 18, the distal end of the middle portion 120 extendspartially into a lumen of the slidable portion 122 of the handle. Oncethe second safety screw 188 has been released, the slidable portion 122of the handle is able to slide over the middle portion 124 of thehandle. The middle portion 124 of the handle includes at its distal endprojections 300 that extend radially outwardly and proximally. These areable to engage with a recess provided in the lumen of the slidableportion 122 of the handle for the reasons described below.

FIGS. 31 to 33 illustrate a proximal end cap provided at the proximalend of the rotatable portion 120 of the handle. The proximal end cap 310is held to the rotatable portion 120 of the device by a retainer clip(not shown). The retainer clip can be removed manually by the surgeon orclinician thereby to remove the proximal end cap 310. This allows therotatable portion 120 of the handle to be removed, and allows manualremoval of the trigger wires. This quick-release mechanism provides amanual by-pass to the handle mechanism by which the elements of theassembly can be withdrawn by pulling in the axial (proximal) directionin a manner analogous to traditional introducer assemblies. This isuseful in cases where complications arise during the medical procedureand where it is necessary to effect rapid deployment or removal of themedical device. Whilst such an emergency deployment procedure isinferior to correct deployment using the handle, it allows the implantto be deployed or removed without resorting to an open is vesselprocedure, which may be necessary should such problems arise duringdeployment using currently known handles.

The slidable portion 122 of the handle includes a sealing rod 4 and asealing cap 350. These can be seen in more detail in FIGS. 34 and 35.The sealing rod 4 extends from the distal end of the middle portion 124of the handle, but is able to slide within a lumen of the middle portion124 of the handle. The distal end of the sealing rod 4 engages withinthe sealing cap 350.

The wall of the rotatable section 82 of the rotatable portion 120 of thehandle includes a window 27. This allows the user to see when the greencoloured marker ring 26 is aligned with the window as described below.

In use, as with the handle illustrated in FIGS. 12 to 15, it is to benoted that the second safety screw 188 cannot be rotated at thebeginning of the deployment procedure because it is engaged with thefirst safety rod 194. Therefore, the first step is for the surgeon orclinician to rotate by 180 degrees the first safety screw 88. Asdescribed above with reference to FIG. 19, this results in the lockingpin rotation member 190 disengaging from the aperture provided in thestationary section 80 of the rotatable portion 120 of the handle. It isthen possible to rotate the rotatable section 82 of the rotatableportion 120 of the handle.

As the rotatable section 82 of the rotatable portion 120 of the handleis rotated, the first bushing 193 moves in a proximal direction withinthe rotatable portion 120 of the handle. This is due to engagement ofits external threading with the internal threading provided in therotatable portion 120 of the handle. As the first bushing 193 moves in aproximal direction, the first safety rod 194, which is engaged by meansof the shoulder 136 with the first bushing 193 is also withdrawn in aproximal direction. At the same time, trigger wires attached to thefirst bushing 193 and constraining the distal bare stent 18 arewithdrawn in a proximal direction thereby releasing the distal barestent 18.

Continued rotation of the rotatable section 82 of the rotatable portion120 of the handle causes continued proximal movement of the firstbushing 193. This proximal movement continues until the first bushing193 meets the marker ring 26. When the first bushing 193 meets themarker ring 26, continued rotation of the rotatable section 82 of therotatable portion 120 of the handle causes proximal movement also of themarker ring 26. As the marker ring 26 moves in a proximal direction, thesecond safety rod 294 is also moved in a proximal direction. Eventually,the radially outwardly extending protrusion 230 meets the chamferedportion 252 provided on the rotation lock 9 to lock together acting toprevent rotation of the handle.

The proximal movement of the first bushing 193 and the first safety rod194 is such that the first safety rod 194 is now disengaged from thelocking pin rotation member 190 corresponding to the second safety screw188. The second safety screw 188 can thus now be rotated 180 degrees inorder to disengage the locking pin rotation member 190 from theindentation 134 provided on the middle portion 124 of the handle. Theslidable portion 122 of the handle can then slide over the middleportion 124 of the handle to withdraw the cap within which the barestent 18 is constrained.

Once the middle portion 124 has slid into the lumen of the slidableportion of the handle 122 approximately to its full extent, theprojections 300 at the proximal end of the middle portion 124 of thehandle engage with the recesses provided in the lumen of the slidableportion 122 of the handle, thereby preventing distal movement of theslidable portion 122 of the handle. This ensures that sliding of theslidable portion 122 of the handle in a proximal direction isirreversible.

Once the slidable portion 122 of the handle has moved proximally to itsfull extent, it is once again possible to rotate the rotatable section82 of the rotatable portion 120 of the handle. This is because proximalmovement of the slidable portion 122 of the handle causes engagementbetween the distal end of the second safety rod 294 and the distal endof the lumen provided in the slidable portion 122 of the handle. Thedistal end of the lumen pushes against the distal end of the secondsafety rod 294 in a proximal direction, thereby causing proximalmovement of the second safety rod 294. This proximal movement causes theradially outwardly extending projection 230 to overcome the resistanceprovided by the chamfered portion 252 of the locking ring 9, therebyallowing further rotation of the rotatable portion 120 of the handle. Asthe slidable portion 122 of the handle is pulled back in a proximaldirection, the outwardly extending protrusion 230 is pushed in aproximal direction, thus allowing further rotation of the locking ring9.

Further rotation of the rotatable section 82 of the rotatable portion120 of the handle results in further proximal movement of the firstbushing 193, and of the marker ring 26 against which it now abuts.Eventually, the first bushing 193 and the marker ring 26 meet the secondbushing 93, to which the proximal trigger wire is attached.

At this point, the green marker ring 26 is located in line with thewindow 27 in the wall of the rotatable section 82 of the rotatableportion 120 of the housing. This signifies that continued rotation ofthe rotatable portion 120 of the handle will result in release of theproximal trigger wires. Continued rotation of the rotatable section 82of the rotatable portion 120 of the handle causes proximal movement ofthe second bushing 93, and therefore withdrawal of the proximal triggerwire attached to the second bushing 93 and release of the proximal endof the implant.

FIG. 37 is a modified version of the handle illustrated in FIGS. 8 to11. It can been seen also, that this version of the handle resembles theversion illustrated in FIGS. 6 to 18, whereby the slidable portion hassimply been locked in its most proximal position.

The handle could also be modified to withdraw also a sheath covering animplant. This could be achieved in a variety of ways, such as byproviding at the proximal end of the sheath one or more wires or tabswhich couple to the handle mechanism or by changing the design of thehandle mechanism to engage and pull the sheath itself. Suchmodifications will be within the ability of a person of average skill inthe art.

FIG. 38 illustrates an embodiment of spool arrangement for winding atrigger wire as this is pulled proximally during deployment. Thearrangement includes a spool element 170 that is substantially circularin shape. The spool element 170 is arranged to rotate with the handlemechanism when the latter is rotated. The spool element 170 has attachedthereto the proximal end of a trigger wire to be withdrawn. The spoolelement 170, in this embodiment, includes a groove 172 around itscircumference. The purpose of this will be described below.

A support member 174 is located just distally of the spool element 170and is rotatably fixed. The support member 174 includes a hole 176passing therethrough which is generally radially aligned with the spoolelement 170. The trigger wire 40 to be withdrawn passes through theaperture 176 of the support member 174.

When the handle assembly is actuated, the spool element 170 rotates,pulling the trigger wire with it, the latter being wound into the grooveor channel, being fed into position by the relatively stationary hole176.

An advantage of the above-described embodiment is that the trigger wirecan be fully withdrawn into the handle. It therefore does not need to beremoved separately.

Various modifications to the embodiments described above may besubstituted for or combined with one another as desired. It is also tobe understood that the various features of the dependent claims appendedhereto may be used with one another in any desired or appropriatecombination of those claims.

The disclosure in the abstract accompanying this application isincorporated herein by reference.

1. A handle for an implant deployment device including: a rotatablemember; a first trigger wire release mechanism, for withdrawing atrigger wire from a portion of an implant; a slidable portion axiallyaligned with the rotatable member and located distally of the rotatablemember, the slidable portion able to be moved longitudinally towards therotatable member; wherein rotation of the rotatable member causes thetrigger wire release mechanism to withdraw a trigger wire so as torelease a portion of an implant, and wherein the slidable portion isonly able to move longitudinally towards the rotatable member aftermovement of the trigger wire release mechanism in a longitudinaldirection.
 2. A handle as claimed in claim 1, wherein the trigger wirerelease mechanism is movable longitudinally with respect to the handle,the first trigger wire release mechanism being engaged with therotatable member such that upon rotation of the rotatable member thefirst trigger wire release mechanism moves in a proximal direction withrespect to the device.
 3. A handle as claimed in claim 2, wherein atrigger wire to be released is attached to the first trigger wirerelease mechanism, such that movement of the trigger wire releasemechanism in a proximal direction results in withdrawal of the triggerwire.
 4. A handle as claimed in claim 2, wherein the rotatable member issubstantially cylindrical and includes a lumen and an internal screwthread, wherein the trigger wire release mechanism is substantiallycylindrical and is located within the internal lumen of the rotatablemember and includes an external screw thread engaged with the internalscrew thread of the rotatable member, and wherein a guide member extendsthrough the trigger wire release mechanism to prevent rotation thereofwhen the rotatable member is rotated.
 5. A handle as claimed in claim 2,wherein a stop is provided so as to allow movement of the trigger wirerelease mechanism for a limited distance in the proximal direction.
 6. Ahandle as claimed in claim 1, including a first releasable lock operableto prevent rotation of the rotatable member.
 7. A handle as claimed inclaim 6, wherein the releasable lock is operable to fix the rotatablemember to a non-rotatable portion of the handle in order to preventrotation of the rotatable member.
 8. A handle as claimed in claim 1,wherein a stop is provided so as to allow movement of the trigger wirerelease mechanism for a limited distance in the proximal direction andwherein the slidable portion is only able to move longitudinally afterthe trigger wire release mechanism has moved by said limited distance.9. A handle as claimed in claim 8, wherein the movement of the slidableportion in a proximal direction disengages the stop, thereby allowingthe trigger wire release mechanism to move longitudinally in a proximaldirection.
 10. A handle as claimed in claim 9, wherein the slidableportion is only able to move longitudinally towards the rotatable memberafter movement of the first trigger wire release mechanism in alongitudinal direction.
 11. A handle as claimed in claim 10, wherein thesecond trigger wire release mechanism is arranged to move longitudinallyin a proximal direction only after the stop has been disengaged.
 12. Ahandle as claimed in claim 11, wherein the trigger wire releasemechanism is able to exert a force in a proximal direction on the secondtrigger wire release mechanism in order to cause the second trigger wirerelease mechanism to move in a proximal direction.
 13. A handle asclaimed in claim 10, wherein the rotatable member is substantiallycylindrical and includes a lumen and an internal screw thread, whereinthe trigger wire release mechanism is substantially cylindrical and islocated within the internal lumen of the rotatable member and includesan external screw thread engaged with the internal screw thread of therotatable member, wherein a guide member extends through the triggerwire release mechanism to prevent rotation thereof when the rotatablemember is rotated, and wherein the second trigger wire release mechanismis substantially cylindrical and is located within the internal lumen ofthe rotatable member proximal of the trigger wire release mechanism, andwherein the second trigger wire release mechanism does not include anexternal screw thread engaged with the internal screw thread of therotatable member.
 14. A handle as claimed in claim 1, including areleasable lock operable to prevent longitudinal movement of theslidable portion.
 15. A handle as claimed in claim 14, whereinreleasable lock is operable to fix the slidable portion to anon-slidable portion of the handle in order to prevent longitudinalmovement of the slidable portion.
 16. A handle as claimed in claim 15,wherein a stop is provided so as to allow movement of the trigger wirerelease mechanism for a limited distance in the proximal direction andwherein the releasable lock can only be released after the trigger wirerelease mechanism has moved by said limited predetermined distance. 17.A handle as claimed in claim 16, wherein the releasable lock engageswith the slidable portion of the handle and with a non-slidable portionof the handle thereby preventing relative movement therebetween, whereinthe releasable lock engages with a longitudinal member attached to andarranged to move with the first trigger wire release mechanism such thatthe releasable lock cannot be released whilst engaged with thelongitudinal member, whereby movement of the trigger wire releasemechanism in a proximal direction causes disengagement of thelongitudinal member from the releasable lock. 18-25. (canceled)
 26. Animplant deployment device including a handle as claimed in claim 1.27-28. (canceled)